FDA Orange Book
Is there a generic for Bylvay?
Bylvay contains odevixibat. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
No. The Orange Book lists no active FDA-approved generic (ANDA) for Bylvay (odevixibat). The Orange Book shows its last listed patent expires November 12, 2041 and its last listed exclusivity ends June 13, 2030.
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Bylvay products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, pellets, oral | 0.2MG | Marketed (Rx) | None | 0 | None |
| capsule, pellets, oral | 0.6MG | Marketed (Rx) | None | 0 | None |
| capsule, oral | 0.4MG | Marketed (Rx) | None | 0 | None |
| capsule, oral | 1.2MG | Marketed (Rx) | None | 0 | None |
NDA 215498, held by IPSEN BIOPHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Bylvay patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 12545705 | November 8, 2031 | Method of use | U-3186 | 215498 |
| 12545705 | November 8, 2031 | Method of use | U-3648 | 215498 |
| 10487111 | November 8, 2031 | Method of use | U-3186 | 215498 |
| 10981952 | November 8, 2031 | Method of use | U-3187 | 215498 |
| 10981952 | November 8, 2031 | Method of use | U-3186 | 215498 |
| 10011633 | November 8, 2031 | Method of use | U-3186 | 215498 |
| 10093697 | November 8, 2031 | Method of use | U-3186 | 215498 |
| 10093697 | November 8, 2031 | Method of use | U-3648 | 215498 |
| 10011633 | November 8, 2031 | Method of use | U-3648 | 215498 |
| 11732006 | November 8, 2031 | Method of use | U-3648 | 215498 |
| 11732006 | November 8, 2031 | Method of use | U-3186 | 215498 |
| 12187812 | November 8, 2031 | Method of use | U-3186 | 215498 |
| 12187812 | November 8, 2031 | Method of use | U-3648 | 215498 |
| 10981952 | November 8, 2031 | Method of use | U-3648 | 215498 |
| 10981952 | November 8, 2031 | Method of use | U-3649 | 215498 |
| 10487111 | November 8, 2031 | Method of use | U-3648 | 215498 |
| 9694018 | March 18, 2034 | Method of use | U-3186 | 215498 |
| 9694018 | March 18, 2034 | Method of use | U-3648 | 215498 |
| 12508234 | June 20, 2039 | Method of use | U-3186 | 215498 |
| 12508234 | June 20, 2039 | Method of use | U-3648 | 215498 |
| 11365182 | June 20, 2039 | Method of use | U-3648 | 215498 |
| 11365182 | June 20, 2039 | Method of use | U-3186 | 215498 |
| 11801226 | June 20, 2039 | Drug product | None | 215498 |
| 12091394 | June 20, 2039 | Drug substance | None | 215498 |
| 11802115 | June 20, 2039 | Drug product | None | 215498 |
| 10975046 | June 20, 2039 | Drug substance | None | 215498 |
| 12447156 | November 12, 2041 | Method of use | U-3186 | 215498 |
| 11583539 | November 12, 2041 | Method of use | U-3186 | 215498 |
Bylvay exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| I-918 | New indication | June 13, 2026 | 215498 |
| NCE | New chemical entity | July 20, 2026 | 215498 |
| ODE-363 | Orphan drug exclusivity | July 20, 2028 | 215498 |
| ODE-436 | Orphan drug exclusivity | June 13, 2030 | 215498 |
Bylvay NDC codes
Questions
Is there a generic for Bylvay?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Bylvay (odevixibat). The Orange Book shows its last listed patent expires November 12, 2041 and its last listed exclusivity ends June 13, 2030.
What is the generic name for Bylvay?
The active ingredient in Bylvay is odevixibat, per the FDA Orange Book.
When does the Bylvay patent expire?
The last patent listed for Bylvay in the Orange Book expires November 12, 2041. A listed patent expiry date is not a generic launch date.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.